Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible. 

Study Description

Hand osteoarthritis (OA) is a common problem and is associated with substantial functional limitations. To date, few therapies are effective in reducing pain in hand OA; and most are only based on expert opinion. Although nodal hand OA has traditionally not been viewed as a biomechanically driven disease, there is growing evidence that indeed it is. OA in the knee, a disease long known to be biomechanically driven, can be treated with distraction, a therapy where external hardware is surgically placed preventing joint motion, providing intra-articular negative pressure, and increasing the joint space. People awaiting knee total knee arthroplasty receiving distraction have reduced pain, growth of new articular cartilage, and delay and sometimes complete avoidance of arthroplasty. Unfortunately, distraction is associated with serious attendant adverse events including a 10% rate of pulmonary emboli despite anticoagulation and an 85% rate of pin site infection, limiting the widespread use of this treatment. Nevertheless, it is an important proof of concept that unloading an OA joint may allow structure and symptom improvement. Since distraction has both symptom and structure benefits in knee OA, then traction therapy, using non-invasive finger traps, may have similar benefits for hand OA without attendant complications. Thus, this study proposes a pilot randomized controlled trial of traction on 100 participants recruited from the Michael E. DeBakey VA Medical Center with at least 3 joints affected by distal interphalangeal (DIP) nodal hand OA, with at least one symptomatic joint.

Participants will be randomized into two groups (1) standard of care or (2) traction with finger traps plus standard of care. Specific aim 1: Feasibility of a static hand-based orthosis to apply finger traps. Specific aim 2. Proof of concept. On a small subsample, the study team will obtain radiographs to assess whether increased joint space is achieved with finger traction. Specific aim 3. Symptomatic and functional outcomes. At baseline, and 1, 3, and 6 month follow up visits, the study team will assess outcomes of the Australian Canadian Hand OA Index (AUSCAN) pain scale, the visual analog scale pain scale, the AUSCAN function subscale, the Functional Index for Hand Osteoarthritis (FIHOA), the Disabilities of the Arm, Shoulder, and Hand (DASH), a hand dexterity test, grip and pinch strength, and tenderness on joint palpation. Specific aim 4. Imaging outcomes. To assess structural benefits of traction therapy, on all participants, bilateral hand radiographs at baseline and at 6 months will be used to assess changes in Kellgren and Lawrence scores, joint space narrowing, and osteophyte scores, and the Verbruggen-Veys score.

ELIGIBILITY CRITERIA:

Ages Eligible for Study:             Child, Adult, Older Adult

Sexes Eligible for Study:           All

Accepts Healthy Volunteers:  No

 

Inclusion Criteria:

  • Enrolled to receive medical care at the Michael E. DeBakey VA Medical Center
  • At least 3 joints affected by distal interphalangeal (DIP) nodal hand OA
  • DIP nodal hand OA will be defined as Heberden's nodes on physical exam.
  • Sufficiently severe frequent pain of at least one DIP
  • Frequent pain: pain on most days of the month for at least one month in the last year.
  • Minimum VAS pain severity of 40 on a 0 - 100 scale

 

Exclusion Criteria:

  • History or current inflammatory arthritides (examples: gout, psoriatic arthritis, and rheumatoid arthritis)
  • Prior surgery on the DIP joints
  • Planned surgery for the DIP joints
  • Pregnancy

Study Design:

Allocation:       Randomized

Intervention Model: Parallel Assignment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose: Treatment

Study Location(s):

Michael E. DeBakey VA Medical Center, Houston, Texas, United States, 77030

Study Website:

https://clinicaltrials.gov/ct2/show/NCT04784065?term=NCT04784065&draw=2&rank=1

 

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